藏药材柳兰质量标准研究

Study on Quality standard of Tibetan Herb Epilobium angustifolium L.

通过对藏药材柳兰的系统研究,建立柳兰的药材质量标准.依据《中国药典》2020年版四部通则,采用性状鉴别、显微鉴别对柳兰药材进行定性鉴别.采用薄层层析法,以金丝桃苷标准品为对照,建立薄层色谱鉴别方法;按四部通则方法对柳兰药材的水分、总灰分、酸不溶性灰分进行检查,测定醇溶性浸出物的含量;采用高效液相色谱法,以金丝桃苷为质控指标,建立指标成分含量测定方法.利用所建方法对不同产地批次的13批样品进行测定和评价,结果建议柳兰药材各检查项指标水分不得超过12.00%,总灰分不得超过10.00%,酸不溶性灰分不得超过2.00%,醇溶性浸出物不得少于25.00%,按柳兰药材干燥品计算,含金丝桃苷(C_(21)H_(20)O_(12))不得少于0.10%.由此所建立的柳兰药材质量标准简单、稳定、可行,为柳兰药材的质量控制及开发应用提供了参考依据.

The quality standard of the Tibetan medicine E.Angustifolium L.is established by studying it systematically.According to the related methods in the Chinese Pharmacopoeia(2020 edition),the qualitative identification of E.Angustifolium L.are carried out by properties and microscopic identify,The TLC identification method is established by using thin layer chromatography(TLC)with hyperoside as control;The moisture,total ash and acid insoluble ash were examined according to the four general principles,and the content of alcohol soluble extract is determined;Moreover,the content determination method of index components is established by adopting HPLC with hyperoside as the indicator of quality control.13 batches of samples from different producing areas are determined and evaluated by using the proposed method.Thus it is suggested that the water content should not be more than 12.00%,the total ash content should not be more than 10.00%,the content of acid insoluble ash should not be more than 2.00%,and the alcohol soluble extract should not be less than 25.00%.According to the dried sample of E.Angustifolium L.medicinal material,the content of hyperoside should not be less than 0.10%.It is concluded that the established quality standard of E.Angustifolium L.is simple,stable and feasible,which provides a reference for the quality control and application of E.Angustifolium L..